Dia-Cem
FDA 510(k) K261166 · DiaDent Group International
510(k) numberK261166
Submission
- Device name
- Dia-Cem
- Applicant
- DiaDent Group International
Cheongju-Si, KR - Received
- April 9, 2026
- Decision date
- July 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | GC America, Inc. | 05/18/2026SE |
| K253337 | REGEN Bioactive CementEMA · Traditional | Inter-Med, Inc. | 04/15/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | Voco GmbH | 03/20/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
| K250953 | Equia LC OneEMA · Traditional | GC America, Inc. | 09/19/2025SE |
More from GC America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261093 | DiafilEBF · Traditional | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | 05/19/2026SE |
| K254112 | Dia-X Sil BiteELW · Traditional | 03/19/2026SE |
| K231552 | Dia-CemEMA · Traditional | 07/28/2023SE |
| K220804 | Dia-X Bond UniversalKLE · Special | 06/15/2022SE |
| K213401 | DIAPLUS UniversalKLE · Traditional | 01/31/2022SE |
| K210421 | Diafil & Diafil CapsuleEBF · Special | 06/28/2021SE |
| K210333 | DiaPasteKIF · Special | 03/25/2021SE |
| K200174 | Dia-Root Bio MtaKIF · Traditional | 09/18/2020SE |
| K200809 | D-Lux+EBZ · Traditional | 08/07/2020SE |
Questions and answers
When was Dia-Cem cleared by the FDA?
Dia-Cem (K261166) received a 510(k) decision of Substantially Equivalent on July 9, 2026, 91 days after the submission was received.
What is the product code of K261166?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.